Steven R. Sarkisian, Jr., MD - VISCO™360 versus SLT Glaucoma Trial
Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval from the US FDA to
Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval from the US FDA to Initiate the VISCO™360 versus SLT Glaucoma Trial Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval from the US FDA to
Study will evaluate the safety and effectiveness of an ab interno procedure for patients with primary open angle glaucoma who do not have co-existing cataracts - the majority of the glaucoma patient population
Although this study is not yet enrolling at DMEI, this technology is already available for select patients at our institute. Dr. Steven Sarkisian was the first surgeon in the country to perform this technique to lower eye pressure. Because the technique is reasonably safe, this FDA study is to help get an indication for using this device even earlier in the disease process.
MENLO PARK, Calif., July 26, 2016 /PRNewswire/ -- Sight Sciences, Inc., a venture-backed, commercial-stage ophthalmic medical device company announced today that it has received full IDE approval from the FDA to initiate the world's first clinical trial comparing ab interno canaloplasty with Selective Laser Trabeculoplasty (SLT). The VISCO™360 versus SLT Glaucoma Trial is a multi-center, prospective, randomized, controlled clinical evaluation that will study the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in canaloplasty versus SLT in the reduction of intraocular pressure (IOP) in primary open angle glaucoma.
The VISCO™360 Viscosurgical System* is a fully integrated, single-handed, single-use device that combines a custom access cannula, a soft and flexible microcatheter with an atraumatic tip, an internal infusion pump and viscoelastic reservoir, and a control wheel that advances and retracts the microcatheter.
Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval from the US FDA toSOURCE Sight Sciences, Inc.
Canaloplasty involves the circumferential catheterization and transluminal viscodilation of Schlemm's canal for the lowering of IOP in patients suffering from glaucoma. The procedure has been around for a decade using an ab externo approach.
Dr. Steven Sarkisian, Professor of Ophthalmology at the Dean McGee Eye Institute at the University of Oklahoma and a principal investigator in the VISCO™360 Study explained, "I have performed hundreds of ab externo canaloplasties over the years with excellent results. I am excited to participate in the VISCO™360 study to characterize the safety and effectiveness of ab interno canaloplasty for patients with primary open angle glaucoma who do not need a combined procedure with cataract surgery. I believe that glaucoma specialists, comprehensive ophthalmologists, and any anterior segment surgeons will find this familiar ab interno approach to canaloplasty extremely useful for the care of their mild to moderate glaucoma patients and I look forward to participating in this important pivotal study".
"We are extremely excited to begin this pivotal clinical trial investigating the use of our VISCO™360 device for this specific indication. We believe there is a huge unmet need for an effective ab interno glaucoma procedure that is not performed in conjunction with cataract removal and we look forward to working with all of our clinical partners in the execution of this large, robust FDA clinical study," stated Paul Badawi, Co-Founder and CEO of Sight Sciences.
Glaucoma is the world's leading cause of irreversible blindness and affects approximately 80 million people worldwide. Often associated with abnormally high IOP, glaucoma is characterized by progressive vision loss due to irreversible optic nerve damage. It is estimated that 20% of people with glaucoma do have co-existing cataracts while 80% of people with glaucoma do not have co-existing cataracts making a stand-alone surgical option like VISCO™360 an important part of an ophthalmologist's armamentarium.
About Sight Sciences: Sight Sciences is a medical device company dedicated to the development of technology-driven solutions that address the underlying physiology of ophthalmic disease. The company operates two business lines: surgical and non-surgical devices. Its surgical product portfolio consists of the TRAB™360 and VISCO™360 surgical devices. Its non-surgical product portfolio consists of technologies in the advanced stages of development for evaporative dry eye. For more information, visit www.sightsciences.com.
*The VISCO™360 device is available in the United States as a manual surgical tool but is investigational in the United States for the specific indication of IOP reduction in adult, pseudophakic patients with primary open angle glaucoma.
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Posted on Wed, July 27, 2016
by Nicole Glenn filed under